OXACILLIN for Injection, USP For Intramuscular or Intravenous InjectionTo reduce the development of drug-resistant bacteria

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

OXACILLIN SODIUM (UNII: G0V6C994Q5) (OXACILLIN - UNII:UH95VD7V76)

Fáanlegur frá:

Piramal Critical Care Inc

Stjórnsýsluleið:

INTRAMUSCULAR

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Oxacillin is indicated in the treatment of infections caused by penicillinase producing staphylococci which have demonstrated susceptibility to the drug. Cultures and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug (See CLINICAL PHARMACOLOGY: Susceptibility Testing ). Oxacillin may be used to initiate therapy in suspected cases of resistant staphylococcal infections prior to the availability of susceptibility test results. Oxacillin should not be used in infections caused by organisms susceptible to penicillin G. If the susceptibility tests indicate that the infection is due to an organism other than a resistant Staphylococcus, therapy should not be continued with oxacillin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Oxacillin for Injection, USP and other antibacterial drugs, Oxacillin for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspecte

Vörulýsing:

Oxacillin for Injection, USP contains oxacillin sodium equivalent to 1 gram or 2 grams oxacillin per vial. NDC 66794-225-02 1 gram vial packaged in 10s NDC 66794-226-02 2 grams vial packaged in 10s Store the dry powder at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Manufactured for: Piramal Critical Care Bethlehem, PA 18017, USA Manufactured by: Haupt Pharma Latina S.r.l. Latina, Italy Product of Italy Rev. 07/19

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

OXACILLIN- OXACILLIN INJECTION, POWDER, FOR SOLUTION
PIRAMAL CRITICAL CARE INC
----------
OXACILLIN FOR INJECTION, USP
FOR INTRAMUSCULAR OR INTRAVENOUS INJECTIONTO REDUCE THE DEVELOPMENT OF
DRUG-RESISTANT BACTERIA AND MAINTAIN THE EFFECTIVENESS OF OXACILLIN
FOR
INJECTION AND OTHER ANTIBACTERIAL DRUGS, OXACILLIN FOR INJECTION
SHOULD BE USED
ONLY TO TREAT OR PREVENT INFECTIONS THAT ARE PROVEN OR STRONGLY
SUSPECTED TO
BE CAUSED BY BACTERIA.
DESCRIPTION
Oxacillin for Injection, USP is a semisynthetic penicillin antibiotic
derived from the penicillin
nucleus, 6-amino-penicillanic acid. It is resistant to inactivation by
the enzyme
penicillinase (beta-lactamase). It is the sodium salt in a parenteral
dosage form for
intramuscular or intravenous use.
Each vial of oxacillin for injection, USP contains oxacillin sodium
equivalent to 1 gram or 2
grams of oxacillin. The sodium content is 64.4 mg (2.8 mEq) per gram
of oxacillin. The
product is buffered with 22 mg dibasic sodium phosphate per gram of
oxacillin. Oxacillin
for injection, USP is white to off white powder and gives a clear
solution upon
reconstitution.
OXACILLIN SODIUM
The chemical name of oxacillin sodium is 4-Thia-1-azabicyclo [3.2.0]
heptane-2-
carboxylic acid, 3,3-dimethyl-6-[[(5-methyl-3-phenyl-4isoxazolyl)
carbonyl] amino]-7-
oxo-monosodium salt, monohydrate, [2S(2α,5α,6β)]. It is resistant
to inactivation by the
enzyme penicillinase (beta-lactamast). The molecular formula of
oxacillin sodium is
C19H18N3NaO5S•H2O. The molecular weight is 441.44.
CLINICAL PHARMACOLOGY
Intravenous administration provides peak serum levels approximately 5
minutes after
the injection is completed. Slow IV administration of 500 mg gives a
peak serum level of
43 mcg/mL after 5 minutes with a half-life of 20-30 minutes.
Oxacillin sodium, with normal doses, has insignificant concentrations
in the
cerebrospinal and ascitic fluids. It is found in therapeutic
concentrations in the pleural,
bile, and amniotic fluids.
Oxacillin sodium is rapidly excreted as unchanged drug in the ur